Treatment with anakinra was not associated with any significant changes, or differences in change vs placebo, in peak Vo2 or the VE/Vco2 slope at 4 wk nor at 12 wk (coprimary end points) or after 12-wk washout (all P values >0.05 at timexgroup interaction analysis). There were no significant changes in peak Vo2 or the VE/Vc02 slope at 4 and 12 wk compared with baseline in either group (all P>0.05). Column height reflects median and bar reflects interquartile range.

There were no statistically significant differences between-group changes in exercise time comparing anakinra and placebo (P=0.96). Within the anakinra-treated patients, treadmill exercise time was longer at 4 wk (+48 s, P=0.004 for within-group) and 12 wk (+27 s, P=0.009 for within-group) vs baseline. After 12 wk of cessation of anakinra therapy, exercise time was not different than the baseline levels (+2 s, P=0.95). Column height reflects median and bar reflects interquartile range.

There was a significantly greater reduction in NT-proBNP levels with 4 wk of anakinra than placebo (P=0.022 [between-group analysis—timexgroup interaction]). There were no changes in NT-proBNP levels in the placebo group at any time point (all P>0.16 vs baseline [within-group analysis]), whereas NT-proBNP levels were lower at 12 wk in the anakinra group (−42% vs baseline, P=0.029 for within-group; however, P>0.05 for timexgroup interaction). Column height reflects median and bar reflects interquartile range.

There were no significant differences in baseline Duke Activity Status Index (DASI) score of Minnesota Living With Heart Failure Questionnaire (MLWHFQ) score and physical domain score between the groups at baseline, and there were no significant between-groups differences on the effects of treatments on any of the outcomes of interest. Patients randomized to treatment with anakinra reported significantly higher perceived functional capacity, as assessed by the DASI question-naire at follow-up (within-group analysis), and quality of life, as shown by the physical domain scores of the MLWHFQ and comprehensive MLWHFQ score (within-group analysis), whereas no placebo-treated patients did not (within-group analysis); however, none of the differences in anakinra vs placebo changes reached statistical significance (timexgroup interaction). Column height reflects median and bar reflects interquartile range.